European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

Pharma Marketing Network

OCTOBER 6, 2021

Given their often niche content, pharma marketers must target smaller, more exclusive audiences to drive results while developing impactful creative. Instead of trying to find new sources of identity, pharma marketers don’t have to look far to replace audience-based targeting. Premium Placement Quality Allows Creative to Shine.

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Pharma Media Digital Media Marketing 98

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

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FDA Doctors Patients Prescription 84

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). It is claimed to be the longest follow-up of any gene therapy programme for SCD.

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Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. That leaves three years for pharma companies to prepare. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments.

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FDA Prescription Medicine Biopharma 52

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 82

PM360

NOVEMBER 29, 2022

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Typically, a drug label refers to any information provided with prescription drugs, as requested by regulators such as the U.S.

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Food and Drug Administration Competition Safety Pharmacology 98

PM360

OCTOBER 13, 2023

Doctor Docs: Targeting Trust Between Pharma and HCPs A new study shows the crucial link in pharma marketers’ digital engagement strategy with HCPs is in jeopardy—trust. and France regarding pharma-provided digital platforms. One participant summed up these perceptions by stating “It’s a pharmaceutical site, you know.

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Healthcare Healthcare Doctors Pharma 59

pharmaphorum

DECEMBER 7, 2022

Pharma companies involved in the sale of heartburn therapy Zantac have won a key battle in litigation brought by patients who claim the drug caused them to develop cancer.

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Sales Prescription FDA Pharma 73

PM360

AUGUST 9, 2022

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. Pharma Manufacturer Solutions. Vincent Keunen.

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Prescription Medical Side effects Patients 105

pharmaphorum

AUGUST 17, 2022

The first lawsuit claiming that gastrointestinal drug Zantac causes cancer has been voluntarily dismissed a week before it was due to come to trial, in an early victory for the pharma companies that will defend themselves from the allegations. “GSK will continue to vigorously defend itself against all claims alleging otherwise.”

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Sales Prescription Manufacturing FDA 52

PM360

SEPTEMBER 21, 2023

Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market.

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Management Manufacturing Sales Competition 105

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Yet, pharma companies spend more than $5 billion on patient support programs every year, and only 3% of patients are using them.

Medical 105

Medical Electronics Patients Healthcare 105

PM360

JUNE 11, 2022

Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. Patients want to know other patients are involved in what pharma is doing. Learn how pharma is involving them. They want to hear about those patients’ experiences.

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Patients Pharma Education Media 59

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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Food and Drug Administration Safety FDA Ethics 10

PM360

DECEMBER 20, 2023

Additionally, it will delve into the current trends and challenges that pharma companies need to consider when devising successful market access strategies for this unique market. Medicines that are not listed in either Category 1 or 2, such as over the counter (OTC) and other prescription therapies (pembrolizumab, CAR-T therapy, etc.),

Marketing 105

Marketing Insurance Medical Manufacturing 105

PM360

SEPTEMBER 15, 2022

People get tired of feeling that they are their sickness; they’re tired of carrying the baggage of being a “patient,” and they want to be seen and treated like the person they are, not the prescription they take. Empathy needs to be a core strategic imperative for pharma brands. This is a tangible human challenge. Michael Zilligen.

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Patients Healthcare Healthcare Marketing 98

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

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Food and Drug Administration FDA Medicine Patients 122

PM360

DECEMBER 14, 2022

From hair loss to allergies and acne, Amazon Clinic allows patients to message clinicians for a diagnosis, treatment, and medication prescription. When Coherus BioSciences received FDA approval for Cimerli , a biosimilar to Roche’s eye disease medicine Lucentis , it was also granted drug interchangeability without requiring a switching study.

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Manufacturing Medical Healthcare Healthcare 52

Pharmaceutical Technology

OCTOBER 25, 2022

More FDC products flowing into pharma pipelines. Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Improved convenience and safety.

Manufacturing 52

Manufacturing Physicians Prescription FDA 52

World of DTC Marketing

MARCH 23, 2021

The media, rather than focus on the real driver of high healthcare costs, loves to point the finger at big pharma. years to win FDA approval, at a median cost of $648 million. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million a drug.

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Pharmaceutical Technology

OCTOBER 10, 2022

After more than a decade in development, Freya Pharma Solutions plans to advance an oral tablet dubbed Lybrido into Phase III trials to treat female sexual interest/arousal disorder (FSIAD). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Clarify Health

DECEMBER 13, 2022

About 10% of pharma companies at this point have active efforts but we’ve started to see some approvals. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption.

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Recruitment Retail Patients Education 52

Clarify Health

DECEMBER 13, 2022

About 10% of pharma companies at this point have active efforts but we’ve started to see some approvals. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence? Mr. Gohil said, “When we look at the FDA, since 2016, the industry overall has seen a good amount of adoption.

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Recruitment Retail Patients Education 52

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52

Pharmaceutical Technology

MARCH 16, 2023

However, health specialists refute most safety concerns for the use of drug classes as part of gender affirming care, citing years of research and care. With restricted access and reduced prescription of puberty blockers and hormone therapies, the impact on pharmaceutical companies manufacturing these therapies also remains unclear.

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Ethics Prescription Safety Healthcare 144

World of DTC Marketing

MAY 6, 2021

The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad. The post Pharma panics over patent wavers.

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Pharma Food and Drug Administration Government Insurance 185